化妆品 — 欧盟颁布新法规

化妆品 — 欧盟颁布新法规





CN-310 / Jan 2010
化妆品 — 欧盟颁布新法规




从2013年7月11日开始，欧洲经济区1
(EEA)市场中销售的化妆品必须符合新颁布的欧盟化妆品法规(EC) No
1223/20092的要求，其中部分要求将先于上述日期开始执行。
这些新的化妆品要求以欧盟法规的形式发布，在27个欧盟成员国(以及挪威、冰岛和列支敦士登)中作为国家法律实施，不像欧盟指令那样在国内执行前需要转换。法规(EC)
No 1223/2009将取代旧的化妆品指令76/768/EEC及其到目前为止的67项修订文件。
新法规简化了欧洲经济区对化妆品的要求，使其成为单一法律，消除了可能在成员国执法过程中产生分歧的内容。化妆品通报只需递交给由中央委员会和COLIPA(欧洲化妆品协会)联合开发的数据库，而不是现在的各个成员国。不过，企业要对自己通报的内容负责，而不是由行业协会代为管理。
2010年12月1日–CMR (致癌、诱导有机体突变或对生殖有毒害的物质3)
禁止使用CMR
1A、1B或2类物质。欧盟的消费者安全科学委员会(SCCS)可能会授予豁免，但危害性更高的1A和1B类CMR还需要符合其它更加严格的标准。
2013年1年11日–纳米材料

除需符合其它通报要求外，2013年1月11日前投放市场的含有纳米材料的化妆品应在2013年7月11日前通过电子方式向委员会通报。
1 欧洲经济区(EEA)包含27个欧盟成员国，以及挪威、冰岛和列支敦士登。
2 OJ L 342, 22.12.2009, p.
59，http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF
3 物质和混合物分类、标签和包装法规(EC) No
1272/2008附件六第3部分1A、1B和2类CMR，http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF
2013年7月11日–所有化妆品–其它要求
责任人
现在，责任人的定义更加明确：
EEA内的生产商
将产品输入EEA的进口商
EEA内进行以下活动的分销商：
o 使用其自

己的名称或商标将化妆品投放市场；或者
o 对化妆品的更改可能影响其法规符合性(不包括仅文字翻译)。
由生产商或进口商指定在EEA内担任责任人的人。指定责任人的要求和协议应为书面方式。
EEA内的生产商为责任人，除非该生产商指定其他人作为代理。
根据新要求，责任人将承担更多的法律责任，主要包括以下内容。
良好生产规范 (GMP)
目前已有统一标准为强制性的良好生产规范提供基准规范，但企业仍然可以采用至少达到GMP同等水平的其它标准或体系。

上述统一标准其实就是为EN ISO 22716: 2007化妆品 – 良好生产规范(GMP) –
良好生产规范指南，当此指南在欧盟官方杂志上刊登时便已成为统一标准了。已有部分欧盟成员国将其转换为国家标准。

良好生产规范符合统一标准EN ISO 22716也即符合此新法规GMP的要求。虽然符合EN
ISO 22716并非强制性，但统一标准为企业提供了最简便的选择。
化妆品安全报告
这一安全评估文件包含两个部分，扩展了之前评估需要考虑的数据范围，其中有些数据是已经存在的。
对每种原材料进行评估，需要以安全边际(MoS)的计算为基础，用于所有显著的毒性吸收途径和系统效果，以及无明显损害作用水平(NOAEL)。没有此类评估的应及时提供理由证明。

在安全评估人员最终签署化妆品安全报告之前，需要提供微生物质量和稳定性测试报告。
根据现行指令76/768/EEC已经通报的产品也需要提供符合新法规的化妆品安全报告。
A部分– 化妆品安全信息
1. 化妆品成份的定量和定性
2. 化妆品的物理/化学特性和稳定性
· 包括稳定性测试报告
3. 微生物质量
· 微生物限量
· 防腐剂有效性测试报告
4. 杂质、痕量物质，以及包装材料的信息

· 原材料的纯度
·
技术上不可避免地存在痕量禁用物质的证据
·
包装材料的规格，包括纯度和稳定性
5. 正常和合理可预见的用途
6. 化妆品的暴露
7. 物质的暴露
8. 物质的毒性信息
9. 不良反应和严重不良反应
10. 化妆品上的信息
· 通过人体自愿者进行的研究
·
其它相关的已验证的风险评估
B部分– 化妆品安全评估
1. 评估结论
2. 标签上的警告，以及使用说明
3. 论证
4. 评估人员的资质和对B部分的核准
产品资料档案 (PIF)
与目前的产品资料套装(PIP)相似，将包括化妆品安全报告和一份GMP符合性声明。
根据现行指令76/768/EEC已经通报的产品也需要提供符合新法规的PIF。
在最后一批产品投放市场后由责任人保存10年。
通报
责任人必须通过数据库向委员会通报每种化妆品，此数据库目前正在建立中。
委员会将向每个成员国的主管当局和毒害管理中心或相关机构传达上述信息。
不再需要在化妆品的销售国进行单独通报。
通报内容应包括：
o 化妆品类别和名称以便识别
o 原产国(从哪里进口至EEA)
o 将要销售的成员国市场
o 在需要情况下可以联络到的实际联系人的详细信息
o
纳米材料–识别和名称(IUPAC)、CAS号码、EINECS或ELINCS号码，非专利商品名
o CMR – 名称(IUPAC)和CAS或EINECS或ELINCS号

码
o 结构公式(仅提供给毒害管理中心或类似机构)
o 原始标签，在可能的情况下提供包装的照片
纳米材料
纳米材料是不能溶解、具有生物持续性，并且人为生产的材料，有一个或多个外部尺寸或一个内部构造，大小为1-100毫微米。

与大粒子的纳米材料相比，非常小的纳米材料粒子可能影响其化学甚至毒物学特征。所以需要额外的详细审查。

化妆品中使用的纳米材料包括二氧化钛、氧化锌、二氧化硅、黑烟末、氧化铁和氧化铝。
除非特别规定，用作着色剂、防腐剂或紫外线过滤剂(参见附件IV至VI)的纳米材料不受这些补充要求的限制。

除有关化妆品的一般通报要求之外，责任人在投放市场前6个月还应通报委员会产品中使用的纳米材料。
每种纳米材料的通报内容包括：
o
识别方法和名称(IUPAC)、CAS号码、EINECS或ELINCS号码，非专利商品名
o 规格，包括粒子尺寸、物理和化学特性
o 对每年投放市场的纳米材料的数量估计
o 毒性资料
o 在相关类型化妆品中使用的安全数据
o 合理可预见的暴露情况
如果委员会对某种纳米材料的安全性存在疑虑，将会咨询欧盟的消费者安全科学委员会(SCCS)。
SCCS有六个月的时间提出意见，但在必要情况下，可能会要求责任人在规定时间内提供进一步资料和信息，在此情况下就要从SCCS收到新的资料后重新计算6个月的时间。
标签
进口至EEA的化妆品必须标明原产国。
最短有效期 – 日期前的文字“有效期至”(“best used before the end
of”)可由新的煮蛋计时器标志取代：

最短有效期煮蛋计时器标志
如果开启后有效期无关紧要(现实实践确认)则无需注明开启后有效期。
成份表中纳米材料的名称后应带有“(nano)”字样。
产品声明
将制定有关正确使用产品声明的通用准则。
分销商

在将产品投放市场前，分销商应确保符合以下标签要求：
o 责任人的姓名或注册名称和地址
o 化妆品的批号或识别信息
o 成份表
o 肥皂、沐浴球和其它小产品的减损
o
有关非预包装的、按买方要求在销售时进行包装的，或为立即销售进行预包装的化妆品的国家法规
现在就是为新的欧盟化妆品法规开始准备的时候了，包括为新的化妆品产品安全报告收集补充资料，以及对GMP体系的审核/升级等，这些将耗费大量时间。所以“遥远的”2013年其实转眼将至！！
Intertek解决方案：
Intertek拥有经验丰富的专家团队，全面把握新法规的要求，可以帮助您为2013年做好准备。作为全球领先的测试、验货和认证服务机构，Intertek为健康和美容产品提供全方位的综合服务，包括安全和功效测试、自愿者人体临床和试用、生物体外测试、产品功效声明的验证、GMP培训和审核、化学和微生物测试，以及毒性评估和基准设定等。我们帮助品牌商和生产商加速全球市场的业务增长，优化供应链的质量和安全，同时降低整体成本。
有关详情及相关服务，请咨询：
深圳 李彤 电话：+86 755 2602 0064
传真：+86 755 2683
7118/9；E-mail：consumergoods.shenzhen@
上海 杨文凯 电话：+86 21 6485 0562
传真：+86 21 6495 9813
Email：Kevin.yang@
广州 周桔容 电话：+86 20 3210 2207
传真：+86 20 3220 6081；E-mail:
consumergoods.guangzhou@


Cosmetic Products – New EU Regulation Published




From 11th July 2013 cosmetic products placed on
the market within the European Economic Area1
(EEA) will have to comply with the new EU
Cosmetic Products Regulation (EC) No 1223/20092.
However, some of the new Regulations
requirements will apply sooner as highlighted
below.

These new cosmetic products requirements are
published as an EU Regulation which takes effect
as national law within each of the 27 EU Member
States (here along with Norway, Iceland and
Liechtenstein too) without the need for the
national implementation necessary with an EU
Directive. Regulation (EC) No 1223/2009
replaces the old Cosmetic Products Directive
76/768/EEC and its 67 amendments, to date.
The new Regulation simplifies the EEA
requirements for cosmetic products into a single
law and removing issues arising from differences
in the national implementing legislation.
Notification of cosmetic products will only have
to be made to the central Commission database,
being developed in liaison with COLIPA, the
European Cosmetics Association, rather than to
each Member State at present. However, each
company will become responsible for their own
notification, rather than have a trade
association take care of it on their behalf.
1st December 2010 - CMRs (substances classified
as carcinogenic, mutagenic or toxic for
reproduction3)
The use of substances classified as CMR category
1A, 1B or 2 shall be prohibited. Exemptions may
be granted by the EU's Scientific Committee for
Consumer Safety (SCCS), with additional
stringent criteria having to be met for the more
hazardous category 1A and 1B CMRs.
11th January 2013 – Nanomaterials

Cosmetic products containing nanomaterials that
were placed on the market prior to 11th January
2013 shall be notified to the Commission by
electronic means before 11 July 2013, in
addition to the other notification requirements.
1 European Economic Area (EEA) comprises the
current 27 European Union Member States, along
with Norway, Iceland and Liechtens

tein.
2 OJ L 342, 22.12.2009, p. 59,
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF
3 CMR categories 1A, 1B and 2 under Part 3 of
Annex VI to the Classification, Labelling and
Packaging of Substances and Mixtures Regulation
(EC) No 1272/2008,
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF
11th July 2013 – All cosmetic products – Other
requirements
Responsible Person
The identity of the Responsible Person is now
more clearly defined as:
Manufacturer within the EEA.
Importer into the EEA.
Distributor within the EEA who:
o Places the cosmetic product on the
market under his own name or trademark, or
o Modifies a cosmetic product in way that
may affect its compliance (but does not include
merely translation).
A person within the EEA appointed by the
manufacturer or importer to act as their
Responsible Person. Both the mandate request
and agreement of the selected person shall be in
writing.
A manufacturer within the EEA is deemed to be
the Responsible Person, unless they mandate
another person to act on their behalf.
The Responsible Person will have many further
legal obligations under the new requirements,
the main points of which are highlighted below.
Good manufacturing practice (GMP)
A harmonised standard will now provide benchmark
criteria for the mandatory good manufacturing
practice. However, other standards or systems
providing at least an equivalent level of GMP
could be used.
This standard is expected to be EN ISO
22716:2007 Cosmetics - Good Manufacturing
Practices (GMP) - Guidelines on Good

Manufacturing Practices; becoming harmonised
when its reference is published in the EU's
Official Journal. It has already been
transposed as a national standard in several
Member States.
Good manufacturing practice in compliance with
the harmonised EN ISO 22716 will then offer a
presumption of conformity to the Regulation's
GMP requirements. While compliance with EN ISO
22716 is not mandatory, its harmonised status
offers the simplest option.
Cosmetic Product Safety Report
Two part safety assessment document, which
broadens the range of data previously
considered. Some of the additional data will be
already be on hand.
Consideration is made of each raw material,
based on calculations of the margin of safety
(MoS) will be required based for all significant
toxicological routes of absorption and systemic
effects, based on a no observed adverse effects
level (NOAEL). The absence of any such
considerations shall be duly justified.
Microbiological quality and stability test
reports will be required before the cosmetic
product safety report can be finally signed off
by the safety assessor.
Required for products already notified under the
current Directive 76/768/EEC.
Part A – Cosmetic Product Safety
Information
1. Quantitative and qualitative
composition of the cosmetic product
2. Physical/chemical
characteristics and stability of the cosmetic
product
· Including stability test
reports
3. Microbiological quality
· Microbiological
specifications
· Preservation challenge

test reports
4. Impurities, traces, information
about the packaging material
· Purity of the raw
materials
· Evidence to support the
technical unavoidability of traces of prohibited
substances
· Packaging material
specifications, including purity and stability
5. Normal and reasonably
foreseeable use
6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the
substances
9. Undesirable effects and serious
undesirable effects
10. Information on the cosmetic
product
· Studies using human
volunteers
· Other relevant, validated
risk assessments
Part B – Cosmetic Product Safety
Assessment
1. Assessment conclusion
2. Labelled warnings and
instructions of use
3. Reasoning
4. Assessor's credentials and
approval of Part B
Product Information File (PIF)
Similar to the current Product Information
Package (PIP), and will include the Cosmetic
Product Safety Report along with a statement of
GMP compliance.
Required for products already notified under the
current Directive 76/768/EEC.
Shall be held by the Responsible Person for ten
years after the last batch of the cosmetic
product was placed on the market.
Notification
The Responsible Person will have to notify each
cosmetic product to the Com

mission via a
database that is under development.
The Commission then makes this information
available to the competent authorities and
poison centres or similar bodies within each
Member State.
Separate notifications in each Member State in
which the cosmetic product is marketed are no
longer required.
This notification shall include:
o Category of cosmetic product and name(s)
by which it is identified
o Country of origin (where imported into
the EEA)
o Member State in which it will be placed
on the market
o Contact details of a physical person to
be contacted if necessary
o Nanomaterials – identification and name
(IUPAC), CAS number, EINECS or ELINCS numbers,
non-proprietary name
o CMRs – name (IUPAC) and CAS or EINECS or
ELINCS numbers
o Frame formulation (only provided to
poison centres or similar bodies)
o Original labelling and, where possible,
a photograph of the packaging
Nanomaterials
A nanomaterial is defined as insoluble or
biopersistant and intentionally manufactured
material with one or more external dimensions,
or an internal structure, on the scale from 1 to
100 nm.
The very small particle size of nanomaterials
may affect their chemical and even toxicological
properties compared to larger particles. Hence
additional scrutiny is required.
Substances used in cosmetic products as
nanomaterials include titanium dioxide, zinc
oxide, silica, carbon black, iron oxide and
alumina.
Nanomaterials used as colourants, preservatives
or UV-filters (Annexes IV to VI) are exempt from

these additional requirements unless expressly
specified.
Six months prior to being placed on the market,
the Responsible Person shall notify use of
nanomaterials to the Commission (in addition to
the general notification for the cosmetic
product).
For each nanomaterial the notification shall
include:
o Identification and name (IUPAC), CAS
number, EINECS or ELINCS numbers,
non-proprietary name
o Specification, including particle sizes,
physical and chemical properties
o Estimate of the quantity of the
nanomaterial placed on the market, per year
o Toxicological profile
o Safety data for use in the relevant type
of cosmetic products
o Reasonably foreseeable exposure
conditions
Where the Commission has safety concerns
regarding a nanomaterial it will request an
opinion from the EU's Scientific Committee for
Consumer Safety (SCCS).
A period of 6 months is allowed for the SCCS
opinion. However, where necessary further data
may be requested from the Responsible Person
within a specified time. In which case a new 6
months period for the SCCS opinion begins on
receipt of all outstanding data.
Labelling
Country of origin will be mandatory for cosmetic
products imported into the EEA.
Date of minimum durability - the preceding text,
"best used before the end of" (in that order)
may be replaced by the new egg timer symbol:

Date of minimum durability egg timer symbol
Period after opening labelling will not be
required where the concept of durability after
opening is not relevant. (Confirming current
practice).
Names

of nanomaterials in the list of
ingredients shall be followed by "(nano)", in
brackets as shown.
Product Claims
Common criteria to justify the use of certain
claims are to be developed.
Distributors
Distributors shall verify compliance of the
following labelling requirements before making a
cosmetic product available on the market:
o Name or registered name and address of
the Responsible Person.
o Batch number or identifying reference
for the cosmetic product.
o List of ingredients.
o Derogations for soap, bath balls and
other small products, if applicable.
o National rules for cosmetic products not
pre-packed, packaged at the point of sale at the
purchaser's request or pre-packaged for
immediate sale.
Now is the time to start preparing for this new
EU cosmetic products legislation. For example,
gathering additional data for the new Cosmetic
Product Safety Report and auditing/upgrading GMP
systems could be time consuming. So the
"distant" 2013 deadline will be upon us very
quickly!!
Intertek solutions:
Intertek's team of experts have a good knowledge
of the new Regulation's requirements, assisting
you to be ready for 2013. As a global leader in
testing, inspection and certification,
Intertek's Healthcare and Beauty Product
Division has developed a comprehensive set of
services including safety and efficacy testing,
clinical and user trials with human volunteers,
in vitro testing, claim substantiation, GMP
training and auditing, chemical and
microbiological testing, along with
toxicological assessment services, and
benchmarking. We enable brands and producers

accelerate their international growth,
optimizing the quality and safety of their
supply chain while reducing overall costs.
Should you have any queries on the above
information, please contact:
Shenzhen Winnie Li Tel: +86 755 2602 0064
Fax: +86 755 2683 7118/9;
E-mail：consumergoods.shenzhen@
Shanghai Kevin Yang Tel: +86 21 6485 0562
Fax: +86 21 6495 9813 Email:
Kevin.yang@
Guangzhou Kitty Zhou Tel: +86 20 3210 2207
Fax: +86 20 3220 6081; E-mail:
consumergoods.guangzhou@